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Scientist Iii, Ard

6-8 years
Not Disclosed
10 April 30, 2025
Job Description
Job Type: Full Time Education: M.Sc./M.Pharm/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Scientist III, ARD
Location: Hyderabad, India
Job Category: Chemistry & Scientific Standards
Job Type: Full-time
Req ID: SCIEN002750

Job Overview:

The Scientist III in Analytical Research and Development (ARD) will support the development of reference materials and engage in analytical method development for synthetic lab samples. The successful candidate will handle various non-routine and routine analytical tests while ensuring compliance with GLP standards, managing the evaluation of reference standards, performing method validation, conducting stability studies, and contributing to research projects within the analytical department.

Key Responsibilities:

  • 55% Reaction Monitoring and Analysis: Support reaction monitoring, scale-up, and final analysis of samples according to monograph/in-house procedures. Participate in project acceptance and execution as per the approved test protocols. Prepare development reports for synthetic support projects.

  • 15% Equipment and Inventory Management: Execute IQ/OQ/PQ for new instruments, procure necessary lab materials, and maintain a GLP-compliant and safe working environment in the lab.

  • 10% Documentation and SOP Preparation: Prepare SOPs, protocols, and reports. Coordinate with the Purchasing department and ensure the calibration of equipment is on schedule.

  • 10% ISO-9001 Certification Support: Actively participate in ISO-9001 certification and recertification processes, manage internal and external QA audits, and promptly address audit findings.

  • 10% Diversity, Equity, Inclusion, and Belonging: Uphold the principles of diversity, equity, inclusion, and belonging within USP India.

Qualifications:

  • Education: MSc. in Analytical Chemistry, Organic Chemistry, or M. Pharm with 6-8 years of experience in Analytical Research and Development, or a Ph.D. with 1-3 years of experience.

  • Experience: Extensive experience with chemical methods and using instruments such as HPLC, GC, FTIR, UV-Visible, and wet chemistry. Exposure to GMP/GLP environments and documentation procedures is essential.

  • Skills:

    • Proficiency in analytical method development and validation.

    • Ability to interpret and evaluate data, troubleshoot technical problems, and multi-task effectively.

    • Strong technical writing and communication skills.

    • Familiarity with LCMS, GCMS, IC, and ICP-MS is advantageous.

    • Knowledge of ELN, Empower, and NuGenesis is a plus.

    • Strong interpersonal skills and ability to function in a team-oriented environment.

Benefits:

USP offers a comprehensive benefits package, including company-paid time off, healthcare options, and retirement savings, ensuring the well-being of employees and their families.